Full-mouth Electronic Toothbrush vs. Conventional Electronic Toothbrush

NCT06561204 | Completed

• 1 other identifier: STUDY00022906
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized, masked-examiner clinical trial is to investigate a full-mouth electronic toothbrush (FMET). The three arms are: 1) FMET + American Dental Association (ADA) approved dentifrice, 2) conventional electronic toothbrush (ETB) + ADA dentifrice and 3) FMET + foam system.

Conditions

Toothbrush; Gingivitis; Plaque

Outcome Measures

Primary Outcomes (2)

• Löe & Silness gingival index (GI)

  Scale 0-3

  Baseline and 30-days

• Turesky modification of the Quigley-Hein index

  Scale 0-5

  Baseline and 30-days

Study Arms (3)

FMET + ADA dentifrice

EXPERIMENTAL

Baseline and 30-day outcome measures will be collected to evaluate the impact of FMET + ADA dentifrice on clinical indicators of gingivitis, plaque, and patient perceptions.

Device: FMET

Conventional electronic toothbrush + ADA dentifrice

NO INTERVENTION

Baseline and 30-day outcome measures will be collected to evaluate the impact of conventional electronic toothbrush + ADA dentifrice on clinical indicators of gingivitis, plaque, and patient perceptions.

FMET + Foam

OTHER

Baseline and 30-day outcome measures will be collected to evaluate the impact of FMET + foam on clinical indicators of gingivitis, plaque, and patient perceptions.

Device: FMET

Interventions

FMET DEVICE

A full-mouth electronic toothbrush

FMET + ADA dentifrice; FMET + Foam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• University of Minnesota School of Dentistry patient of record who is 18 years of age or older.
• Documented periodontal classification of mild to moderate gingivitis (\>10% BOP) or documented gingivitis on an intact, reduce, or stable with a history of periodontitis in AxiUm electronic health record (EHR) \>10% BOP.
• A minimum of 25% plaque measured O'Leary plaque score.
• A minimum of five natural teeth in each quadrant (excluding third molars, dental implants or teeth with more that ½ of natural surface restored).
• Be willing to abstain from all professional oral hygiene care (prophy/periodontal maintenance) during the study.
• Be willing to abstain from the use of any other dental cleaning aids (dental floss, water flossers, interdental brushes, dental or tooth picks, mouthwash, etc.) during the study.
• Access to personal email account and a device connected to the internet to complete questionnaires and communicate with study team.

You may not qualify if:

• Presence of aggressive, necrotizing, uncommon periodontal disease, or any uncontrolled periodontal condition.
• Presence of any physical limitation or restriction that might preclude normal oral hygiene procedures (i.e. need another individual to perform oral self-care).
• Fixed prosthesis (i.e. implant retained denture), orthodontic appliance or under orthodontic treatment.
• Any medication that may impact periodontal conditions (i.e., phenytoin, calcium antagonists, cyclosporin, warfarin, antimicrobials, or steroids).
• Have any uncontrolled medical condition or immunocompromised that may impact the study (i.e. uncontrolled diabetes HbA1c \> 7, HIV).
• Pregnant, planning to become pregnant, or unsure of pregnancy status (self-reported)
• ≥2 weeks of antibiotic use in the past three months. Or antibiotic use in the last six weeks.
• Cigarette use within the last year
• Unable to comply with the study protocol

Sponsors & Collaborators

• University of Minnesota: lead
• FENO.Co: collaborator

Study Sites (1)

University of Minnesota School of Dentistry

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Gingivitis; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Michelle C Arnett, MS

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 19, 2024
• Study Start: December 30, 2024
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)